MODIFICATION TO AQUADEX FLEXFLOW SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AQUADEX SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYSTEM 100 ULTRAFILTRATION CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Nox RIP Belts & Cables

FDA 510(k)

FDA Class 2 ·Anesthesiology

STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CATHETER, MEDIASTINAL&PERICARDIAL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DISPOSABLE SUCTION AND IRRIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SUCTION IRRIGATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104

FDA 510(k)

FDA Class 2 ·Anesthesiology

TITANIUM HARTSHILL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

THE BONE TIE

FDA 510(k)

FDA Class 2 ·Orthopedic

DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2

FDA 510(k)

FDA Class 2 ·Cardiovascular

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK)

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

PANTHER Cutter Stapler

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery